MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. ATLAS PTA DILATATION CATHETER; PTA BALLOON DILATATION CATHETER

Model Number	AT75204
Medical Device Problem Codes	Material Frayed (1262); Material Rupture (1546); Unraveled Material (1664)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device history records have been reviewed with special attention to the raw materials, subassemblies, manufacturing process, and quality control testing.This lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for these events.The device was returned for evaluation.A visual inspection found frayed and unraveled fibers on the balloon.The device was inflated during functional testing and water was seen exiting from the balloon.The fibers were removed, and a longitudinal rupture was identified.Therefore, the investigation is confirmed for frayed and unraveled material, as well as a longitudinal rupture.The definitive root cause is unknown.The device is labeled for single use.The information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
Event or Problem Description
This report summarizes one malfunction event.A review of this event indicated that model at75204 pta balloon dilatation catheter experienced frayed material, longitudinal rupture, and unraveled material.This report was received from one source.One patient was involved with no patient consequences.The patient is a (b)(6)-year-old male.Patient weight was not provided.

• Brand Name: ATLAS PTA DILATATION CATHETER
• Common Device Name: PTA BALLOON DILATATION CATHETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 8565143
• Report Number: 2020394-2019-00531
• Device Sequence Number: 16692520
• Product Code: LIT
• UDI-Device Identifier: 00801741062520
• UDI-Public: (01)00801741062520
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Model Number: AT75204
• Device Catalogue Number: AT75204
• Device Lot Number: GFCP3945
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/31/2019
• Initial Report FDA Received Date: 04/30/2019
• Patient Sequence Number: 1